Medtronic (NYSE:MDT) said today that it won FDA approval for a clinical trial of its Infuse bone graft in transforaminal lumbar interbody fusion spine procedures.
The Minneapolis-based company started recruiting for the prospective, randomized pivotal trial, which is slated to enroll up to 1,000 patients. The TLIF trial would be the second clinical trial for Infuse, after the FDA approved a separate study in 2017 for posterolateral fusion procedures, which is still enrolling patients.
“With 17 years of clinical use, Infuse bone graft has become one of the most extensively-researched biologic technologies commercially available today,” spine SVP Jacob Paul said in prepared remarks. “Medtronic continues to invest in scientific evidence on Infuse to continue adding to the growing body of clinical data, and we believe these trials will generate additional data to expand indications, increase access to surgeons, and alleviate pain and restore health for patients around the world.”
“The potential to expand the indications for use of Infuse in posterior spine procedures may give a broader group of patients access to this novel biologic technology,” added Indiana Spine Group orthopedic spine surgeon Dr. Joseph Smucker. “When considering the patient, site and procedure, Infuse can be a powerful option in a spine surgeon’s armamentarium. This study has the potential to add to the broader clinical and scientific evidence regarding use of Infuse, and may allow surgeons to better understand its safe and effective use in TLIF procedures.”
The controversial graft made waves in 2008 after concerns arose about off-label sales promotion. Lawsuits and a Spine Journal issue in 2011 dedicated to concerns about Infuse’s safety led to U.S. Justice Dept. and U.S. Senate probes into the compound and its maker’s marketing practices. An independent study found found that, although Infuse is equivalent to iliac crest bone grafts, Medtronic-sponsored trials of the product were biased. In 2014, the company inked a $22 million deal to settle about 950 Infuse product liability lawsuits.
Despite settlements, in 2016, then-Sen. Al Franken (D-Minn.) pushed for a review of a Medtronic Infuse study. A five-year delay in reporting the study’s results from Medtronic led to no action from the FDA, which in turn defended its response to the delay two months after Franken’s claims.
